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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC OCCLUSION CATHETER

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EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC OCCLUSION CATHETER Back to Search Results
Model Number ICF100
Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
Patient Problem No Patient Involvement (2645)
Event Date 11/26/2018
Event Type  Injury  
Manufacturer Narrative
The intraclude device is essential to occlude the aorta and provide the necessary cardiac isolation required to perform minimally invasive cardiac surgery procedures. In this case, it was reported that the catheter shaft of the intraclude device ¿degloved¿ from the main catheter body near the hub. An exchange of the device was required and another occlusion method was implemented. In this case, minimal information regarding this event was received and attempts to get additional information regarding the condition of the device, patient's medical history, or possible comorbidities have been unsuccessful. If new information becomes available or the device is returned for evaluation, a supplemental report will be submitted.
 
Event Description
It was reported that the sheath of an intra-aortic occlusion catheter began to "deglove" from the main catheter body near the hub. The intra-aortic occlusion catheter was removed and another occlusion method was implemented. No patient injury was noted. No additional details were provided.
 
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Brand NameINTRACLUDE
Type of DeviceINTRA-AORTIC OCCLUSION CATHETER
Manufacturer (Section D)
EDWARDS LIFESCIENCES
one edwards way
irvine CA 92614
Manufacturer (Section G)
EDWARDS LIFESCIENCES LLC
one edwards way
irvine CA 92614
Manufacturer Contact
amritha srinivasan
one edwards way
mle-2
irvine, CA 92614
9492504062
MDR Report Key8186821
MDR Text Key131132376
Report Number3008500478-2018-00100
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132175
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/14/2020
Device Model NumberICF100
Device Catalogue NumberICF100
Device Lot Number61704542
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/20/2018 Patient Sequence Number: 1
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